Trial Outcomes & Findings for Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin) (NCT NCT02354235)

Results Overview

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

Baseline, 24 Weeks

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Canagliflozin+Teneligliptin Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
Overall Study STARTED	70	68
Overall Study COMPLETED	67	61
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Canagliflozin+Teneligliptin Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
Overall Study Adverse Event	2	2
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	3
Overall Study Conflict with the stopping criteria	0	1

Baseline Characteristics

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canagliflozin+Teneligliptin n=70 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=68 Participants Placebo for 24 weeks in combination with Teneligliptin	Total n=138 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=9 Participants	52 Participants n=6 Participants	100 Participants n=9 Participants
Age, Categorical >=65 years	22 Participants n=9 Participants	16 Participants n=6 Participants	38 Participants n=9 Participants
Sex: Female, Male Female	16 Participants n=9 Participants	15 Participants n=6 Participants	31 Participants n=9 Participants
Sex: Female, Male Male	54 Participants n=9 Participants	53 Participants n=6 Participants	107 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Full analysis set, last observation carried forward

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.

Outcome measures

Outcome measures
Measure	Canagliflozin+Teneligliptin n=70 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=68 Participants Placebo for 24 weeks in combination with Teneligliptin
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)	-0.97 percentage of HbA1c Standard Error 0.10	-0.10 percentage of HbA1c Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.

The change from baseline in fasting plasma glucose level collected at Week 24.

Outcome measures

Outcome measures
Measure	Canagliflozin+Teneligliptin n=69 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=67 Participants Placebo for 24 weeks in combination with Teneligliptin
Change From Baseline in Fasting Plasma Glucose Level	-34.9 mg/dL Standard Error 3.4	3.9 mg/dL Standard Error 3.5

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.

The percentage change from baseline in body weight collected at Week 24.

Outcome measures

Outcome measures
Measure	Canagliflozin+Teneligliptin n=69 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=67 Participants Placebo for 24 weeks in combination with Teneligliptin
Percentage Change in Body Weight From Baseline	-3.32 percent change Standard Error 0.31	-0.99 percent change Standard Error 0.31

SECONDARY outcome

Timeframe: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks

Population: Full analysis set

The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.

Outcome measures

Outcome measures
Measure	Canagliflozin+Teneligliptin n=67 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=61 Participants Placebo for 24 weeks in combination with Teneligliptin
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)	-105.9 hour*mg/dL Standard Error 7.6	-5.6 hour*mg/dL Standard Error 8.0

SECONDARY outcome

Timeframe: 2 Hours Postprandial, at Baseline and 24 Weeks

Population: Full analysis set

The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Outcome measures

Outcome measures
Measure	Canagliflozin+Teneligliptin n=67 Participants Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=61 Participants Placebo for 24 weeks in combination with Teneligliptin
Change From Baseline in 2-hour Postprandial Plasma Glucose Level	-60.1 mg/dL Standard Error 4.9	-9.2 mg/dL Standard Error 5.1

Adverse Events

Canagliflozin+Teneligliptin

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo+Teneligliptin

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Canagliflozin+Teneligliptin n=70 participants at risk Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=68 participants at risk Placebo for 24 weeks in combination with Teneligliptin
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	1.4% 1/70	0.00% 0/68
Nervous system disorders Cerebral infarction	0.00% 0/70	1.5% 1/68
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/70	1.5% 1/68

Other adverse events

Other adverse events
Measure	Canagliflozin+Teneligliptin n=70 participants at risk Canagliflozin for 24 weeks in combination with Teneligliptin	Placebo+Teneligliptin n=68 participants at risk Placebo for 24 weeks in combination with Teneligliptin
Infections and infestations Nasopharyngitis	18.6% 13/70	16.2% 11/68

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER